Perspectives on Heart Valve Modelling: Contexts of Use, Risk, Validation, Verification and Uncertainty Quantification and End-to-End Example

This chapter provides an introduction to verification and validation (V&V) as it relates specifically to the simulation of heart valves and outlines the importance and nuances from an engineering perspective. The discussion focuses on an industrial V&V process for structural modelling of an implantable device, presented as an end-to-end example. This example demonstrates the application of the ASME V&V 40 standard to the credibility assessment of a transcatheter aortic valve (TAV) FEA model, used in design verification (21CFR 820.30(f)) activities. In particular, the FEA model is utilized for structural component stress/strain (metal fatigue) analysis, in accordance with practices outlined in ISO5840-1:2021. The rapid expansion of modelling and simulation across the heart valve life cycle has necessitated codification of a risk-based framework for model VVUQ (verification, validation, uncertainty quantification). ASME VV40, recognized by the FDA, provides this framework. The framework is flexible in its implementation and can be applied to models spanning a wide range of contexts of use and risk levels. It is ultimately up to the end user to ensure that model credibility is commensurate with the risk associated with the model.